Registration of Food Supplement in Australia

Complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.

In Australia, the TGA oversees regulating pharmaceuticals and other therapeutic commodities. Before higher-risk medications can be supplied lawfully in Australia, they evaluate them for efficacy, quality, and safety. The question of whether a product performs as promised is known as its efficacy. 

Lower risk medications’ safety and quality are regulated by limiting their use to pre-approved low-risk substances and pre-approved low-risk or minor medical problems, as well as by enforcing high manufacturing standards. If they perform a formal compliance review of the medicine, the commercial sponsor is also obliged to have proof that their product is effective, and they are obligated to furnish the TGA with this proof.

The strategy used by the TGA lowers the price of approving low-risk medications. Should we evaluate every low-risk product for effectiveness prior to allowing it on the market, the extra expenses would be transferred to the end user.

Vitamins are controlled as either prescription drugs or complementary medications, depending on the vitamin and dosage. Most vitamins are classified as low-risk supplementary medications, which means that the TGA solely oversees their quality and safety.